Trial to Evaluate the Effectiveness of a Digital Therapeutics in Adults Diagnosed With Major Depressive Disorder

Otsuka Pharmaceutical Development & Commercialization, Inc.386 enrolled

Overview

This study compares the effectiveness of 2 digital therapeutics in adult participants diagnosed with major depressive disorder (MDD) who are on antidepressant therapy (ADT) monotherapy for the treatment of depression.

This is a pivotal, 13-week, multi-center, randomized, controlled trial to evaluate the effectiveness and safety of two digital therapeutics in adult participants diagnosed with MDD who are on antidepressant therapy (ADT) monotherapy for the treatment of depression. The trial consists of a 3-week screening period, a 6-week treatment period, and a 4-week extension. Trial visits will be conducted remotely either by video visit or telephone. The screening visit may be performed in person at the discretion of the investigator. Eligible participants will be randomized to 1 of 2 digital therapeutics within a mobile application that will reside on the participant's personal iPhone or smartphone. The trial population will include male and female participants between 22 and 64 years of age with a primary diagnosis of major depressive disorder (MDD) who are on an ADT for the treatment of depression. This trial will analyze data gathered from approximately 360 participants in the United States. An interim analysis will be conducted when a targeted sample of the first 180 participants has completed week 6 or discontinued the trial prior to week 6.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

386

Conditions

Major Depressive Disorder

Interventions

CT-152 - Digital TherapeuticDEVICE

CT-152 mobile app was used by the participants as per the schedule specified in the respective arm.

ShamDEVICE

Sham mobile app was used by the participants as per the schedule specified in the respective arm.

Eligibility

Sex: ALLMin age: 22 YearsMax age: 64 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Participants with a current primary diagnosis of MDD. * Participants with a Hamilton Rating Scale for Depression, 17-item (HAM-D17) score ≥ 18 * Participants who are receiving treatment with an adequate dose and duration of an ADT and who are willing to maintain that same treatment regimen for the duration of this trial. * Participants who are the only users of an iPhone or an Android smartphone, and agree to download and use the digital mobile application as required by the protocol. Key Exclusion Criteria: * Participants with an inadequate response to \> 1 adequate trial of ADT for the current episode. * Participants who are receiving or have received psychotherapy within 90 days prior to screening. * Participants who are currently using a computer, web, or smartphone software-based application for mental health or depression. * Participants with a history of schizophrenia, schizoaffective disorder, other psychotic disorder, or Bipolar I/II disorder, or current posttraumatic stress disorder, panic disorder, obsessive-compulsive disorder, or personality disorder * General Anxiety Disorder/social anxiety can be present as long as they are not the main disorder requiring treatment.

Locations (1)

For additional information regarding sites, contact 844-687-8522

Dallas, Texas, United States

Outcomes

Primary Outcomes

Change From Baseline to Week 6 in the MADRS Total Score

The MADRS is used to assess depressive symptom severity. It consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts), each rated from 0 to 6 with zero being the "best" rating and 6 being the "worst" rating. The MADRS total score is the sum of ratings for all 10 items. The total score ranges from 0 to 60. A higher score on the MADRS represents a more severe level of depression. A negative change from baseline indicates improvement. Least square (LS) mean was estimated using Mixed Model Repeated Measures (MMRM) method.

Time frame: Baseline (Day 1) to Week 6

Secondary Outcomes

Change From Baseline to Week 6 in the GAD-7 Total Score

The GAD-7 is self-reported questionnaire designed to assess anxiety in participants. The scale contains 7 items (anxiety symptoms) and each item was rated by the participants from 0 (not at all) to 3 (nearly every day) based on how much they were bothered by each symptom. The total score ranges from 0 to 21. A higher score on the GAD-7 represents greater anxiety symptomatology. A negative change from baseline indicates improvement. LS mean was estimated using MMRM method.

Time frame: Baseline (Day 1) to Week 6

Data from ClinicalTrials.gov

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